Catalog Number

LCECVM

Brand Name

IMMULITE® Systems CEA Calibration Verification Material

Version/Model Number

10373684

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K143639

Product Code

JJX

Product Code Name

SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

Public Device Record Key

6bc8609c-c9d9-4566-b2da-363db8b0c5fe

Public Version Date

November 18, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-